Psychomotor AgitationPhase 4NCT02361476
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
A Phase 4 study testing Clonidine in people with Psychomotor Agitation, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Psychomotor Agitation
- What is being tested?
- Clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 379 participants
- Where
- 3 sitesDenmark
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- scheduled for surgery with Sevoflurane as the choice of anesthesia.
Who cannot join
- ASA classification >2
- Premedication with Clonidine
- Ex-premature (born before week 37+0 AND <60 weeks old)
- Intubated before anaesthesia and/or no plans for extubation after anaesthesia.
- Critical illness with haemodynamic instability.
- Active bleeding.
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- Cancer.
- Cardiac diseases including arrhythmias.
- Malignant hyperthermia.
- Mental retardation.
- Neurological illness with agitation-like symptoms.
- Weight >50 kg.
- Allergy to Clonidine.
- Patients treated with methylphenidate / Concerta.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
The Juliane Marie Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Region Sjælland, 2100
Køge Sygehus, Anæstesiologisk Afdeling
Køge, 4600
Anæstesiologisk afdeling, Vejle Sygehus
Vejle, 7100
About this study
Official title: Does Intraoperative Clonidine Reduce Post Operative Agitation in Children Anaesthetised With Sevoflurane? A RCT Including Pharmacokinetic Investigation.
Clonidine is widely used off-label in children for several indications. Clonidine is used for treatment and/or prevention of postoperative agitation in children anaesthetised with Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators don´t have data for characterization of the pharmacokinetic profile among age-groups for children 1-6 years.
In this study the investigators want to investigate if IV Clonidine administered at the end of surgery can prevent/reduce postoperative agitation. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.
Read the detailed description
BACKGROUND:
Clonidine is widely used off-label in children for several indications such as treatment and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However, the current level of evidence in support of Clonidine treatment for postoperative agitation in children remains limited. In addition, the pharmacokinetic profile of intravenous Clonidine in children is not well characterized for age-groups.
METHODS/DESIGN:
In this prospective multicentre double-blinded randomized clinical trial, the investigators aim to investigate the impact of intravenous (IV) Clonidine administered at the end of surgery, on the incidence and degree of postoperative agitation. Children will be assigned to either the intervention or the placebo group. The allocation will be carried out centrally and stratified based on age and trial-site, with152 patients allocated to each group. In the intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20 minutes before the expected completion of the surgery (as assessed by the surgeon). In the control group; Saline (placebo) is injected in equal quantity during surgery at the same time. The drugs are concealed in identical blinded ampoules.
The primary outcome is postoperative agitation measured on the Watcha scale. Secondary outcomes include measurements of postoperative pain relief and adverse effects, including 30-day follow-up.
Twenty of the patients age 1-2 years and twenty age >2 years, with a peripheral venous access in place, will be allocated to drug assay sampling; enabling a compartmental PK analysis based on age group, using non-linear mixed effects models.
- Conditions
- Psychomotor Agitation
- Being tested
- Clonidine, Placebo
- Keywords
- Anaesthesia, Children, Clonidine, Sevoflurane, Postoperative agitation, Prevention, Pharmacokinetics, Safety
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called catapresan
Injection - during surgery
PlaceboDrug
Also called NaCl
Injection - during surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clonidine : injection og 3 micg/kg IV during the operation. Receives: Drug: Clonidine |
| Placebo | Placebo comparator | Placebo : injection og equal amount of NaCl IV during the operation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Agitation
Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated
Measured: 1 day
Secondary outcomes (4)
Fentanyl and Morphine Requirements
Amount used
Measured: Recorded during the stay in the postoperative recovery room
Pain Assessment
Pain score used:
FLACC score = Face, Legs, Activity, Cry, Consolability Score ranges from 0 to 10 (severity increases with increasing score) Pain is FLACC score more than 3
Measured: recovery room - hours
First Administration of Fentanyl or Morphine
Time to administration
Measured: recovery room
Adverse Events
Measured: from intervention to discharge from the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mogens Ydemann, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Steen Henneberg, MD, DMSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361476
- Sponsor's protocol ID
- H - 2 - 2014 - 072
- Status last verified
- Sep 2018
- First submitted
- 1 Feb 2015
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative alpha(2)-adrenergic agonists on postoperative behaviour in children. Br J Anaesth. 2014 Jun;112(6):982-90. doi: 10.1093/bja/aeu093. Epub 2014 Apr 11.
PubMed 24727829Ydemann M, Nielsen BN, Henneberg S, Jakobsen JC, Wetterslev J, Lauritsen T, Steen N, Edstrom B, Afshari A; PREVENT AGITATION Research Group. Intraoperative clonidine for prevention of postoperative agitation in children anaesthetised with sevoflurane (PREVENT AGITATION): a randomised, placebo-controlled, double-blind trial. Lancet Child Adolesc Health. 2018 Jan;2(1):15-24. doi: 10.1016/S2352-4642(17)30127-X. Epub 2017 Nov 2.
PubMed 30169192Ydemann M, Nielsen BN, Wetterslev J, Henneberg S, Lauritsen T, Steen N, Edstrom B, Afshari A. Effect of clonidine to prevent agitation in children after sevoflurane anaesthesia: a randomised placebo controlled multicentre trial. Dan Med J. 2016 Jun;63(6):A5234.
PubMed 27264945